Catalog Number

01-1402-0012

Brand Name

Orthopediatrics Instrumentation

Version/Model Number

01-1402-0012

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 29, 2021

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FZX

Product Code Name

Guide, surgical, instrument

Public Device Record Key

e4dd99d1-5989-4ec7-9459-b463bf8cbb63

Public Version Date

September 30, 2021

Public Version Number

2

DI Record Publish Date

March 05, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-